2014-04-07 13:11:23
On January 17, EFSA put its draft opinion on the assessment of the risks associated with bisphenol A (BPA) for the human population for consultation. This opinion presents the results of an analysis of more than 450 studies on the potential health risks associated with BPA, and concludes, while underlining the context of very high scientific uncertainty, that BPA does not present risks for consumers at current levels of exposure, via feeding and handling thermal tickets. However, the EFSA proposes a reduction in the acceptable daily intake, established on a provisional basis, with a view to preventing the risks which it considers to be low with regard to consumer exposure.
In view of the work it has carried out over more than three years on these issues, ANSES wished to contribute to this consultation and sent its opinion to EFSA on 13 March. The expert appraisal focused on the main key points relating to the dangers of the substance and its health effects, highlighted by the ANSES reports published in 2011 and 2013. It also focused on the new elements of the risk assessment approach proposed by EFSA.
Additional information obtained through recent studies
The integration of new studies into EFSA’s expert appraisal has made it possible to provide additional information, in particular for certain critical effects such as metabolism, for which relatively little information was available until recently.
In fact, EFSA has incorporated recent publications into its risk assessment, published since June 2012, the deadline for publications taken into account by ANSES in its expert report on the assessment of the health risks associated with BPA published in March 2013.
ANSES also notes that, for this new health risk assessment, not only were oral exposure studies evaluated, but the subcutaneous route was also taken into account, which was not the case in previous EFSA opinions.
In addition, EFSA has extended its selection to studies that it has not previously considered, thus taking additional work into account in its risk assessment.
Methodologies to be specified
ANSES emphasizes the important scientific work carried out by EFSA. Nevertheless, it considers that the approach implemented has certain limitations. Thus, certain biochemical or histological manifestations that might lead to health risks are not considered sufficiently conclusive to be retained by EFSA (in particular effects on the central nervous system or on the mammary gland), whereas ANSES still considers it necessary to integrate them into the risk assessment.
In addition, the EFSA report repeatedly mentions uncertainties regarding the effects of BPA in relation to the quality of the studies assessed. However, in its report, the EFSA often uses uncertainty as an argument to consider that an effect is not probable and even sometimes to exclude from the risk assessment an effect that is considered probable.
Agency recommendations
After analyzing EFSA’s draft opinion, ANSES considers that the conclusions of its assessment published in March 2013 remain valid to date. The Agency nevertheless takes note of the number of publications subsequent to its report on the health effects of BPA and considers it necessary to continue active monitoring to update the data on this substance.
Finally, given the differences in interpretation noted by the experts, particularly concerning the methodological limits of toxicity studies on BPA, ANSES recommends defining objective criteria, which should be harmonized between EFSA and national health security agencies.
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